Dipl.-Phys.

König, Niels

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  • Publication
    Towards automated CAR-T Cell Manufacturing. Keeping up with Technological Advancement
    ( 2023-05-04)
    Herbst, Laura
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    Erkens, Frederik
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    Hort, Simon orcid-logo
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    Bäckel, Niklas
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    Nießing, Bastian
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    Popp, Georg
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    Franz, Paul
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    König, Niels orcid-logo
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    Hudecek, Michael
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    Rafiq, Qasim
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    Goldrick, Stephen
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    Papantoniou, Ioannis
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    Schmitt, Robert H.
    The AIDPATH project has received funding from the European Union's Horizon 2020 research and innovation programme under grant agreement no 101016909. The material presented and views expressed here are the responsibility of the author(s) only. The EU Commission takes no responsibility for any use made of the information set out.
  • Publication
    Needle to needle robot‐assisted manufacture of cell therapy products
    ( 2022)
    Ochs, Jelena
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    Hanga, Mariana P.
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    Shaw, Georgina
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    Duffy, Niamh
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    Kulik, Michael
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    Tissin, Nokilaj
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    Reibert, Daniel
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    Biermann, Ferdinand
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    Moutsatsou, Panagiota
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    Ratnayake, Shibani
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    Nienow, Alvin
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    König, Niels orcid-logo
    ;
    Schmitt, Robert
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    Rafiq, Qasim
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    Hewitt, Christopher J.
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    Barry, Frank
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    Murphy, J. Mary
    Advanced therapeutic medicinal products (ATMPs) have emerged as novel therapiesfor untreatable diseases, generating the need for large volumes of high-quality,clinically-compliant GMP cells to replace costly, high-risk and limited scale manualexpansion processes. We present the design of a fully automated, robot-assistedplatform incorporating the use of multiliter stirred tank bioreactors for scalable pro-duction of adherent human stem cells. The design addresses a needle-to-needleclosed process incorporating automated bone marrow collection, cell isolation,expansion, and collection into cryovials for patient delivery. AUTOSTEM, a modular,adaptable, fully closed system ensures no direct operator interaction with biologicalmaterial; all commands are performed through a graphic interface. Seeding of sourcematerial, process monitoring, feeding, sampling, harvesting and cryopreservation areautomated within the closed platform, comprising two clean room levels enablingboth open and closed processes. A bioprocess based on human MSCs expanded onmicrocarriers was used for proof of concept. Utilizing equivalent culture parameters,the AUTOSTEM robot-assisted platform successfully performed cell expansion at theliter scale, generating results comparable to manual production, while maintaining cellquality postprocessing.